Petition for Writ of Certiorari — George P. Naum, III, Petitioner v. United States
Supreme Court briefApr 20, 2021
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IN THE
SUPREME COURT OF THE UNITED STATES
GEORGE P. NAUM III
Supreme Court, U.S.
FILED
APR 2 0 2021
OFFICE OF THE CLERK
Petitioner-Appellant,
v.
UNITED STATES OF AMERICA,
Respondent-Appellee.
On Petition for Writ of Certiorari to the
United States Court of Appeals for the Fourth Circuit
PETITION FOR WRIT OF CERTIORARI
RONALD W. CHAPMAN II
CHAPMAN LAW GROUP
Counsel of Record for Petitioner-Appellant
1441 W. Long Lake Rd., Ste. 310
Troy, Michigan 48098
(248) 644-6326
QUESTION PRESENTED FOR REVIEW
Justice Potter Steward’s concerns raised at oral argument in United States v.
Moore, 423 U.S. 122 (1975) over 40 years ago have become a reality.
And is it not true that historically most, if not all of the great
breakthroughs and advances in medical science are made by people who
did not follow the conventional way of doing things. They followed a new
way, their way, and most of the conventional physicians of their day
would have disagreed with them because this is not the way it has
always been done ... it bothers me that this kind of evidence ... is the
basis for criminal liability. This man was a physician, he was not a
fraud.
United States v. Moore, 423 U.S. 122 (1975); Oral Argument in United States v. Moore,
Oyez, https://www.oyez.org/cases/1975/74-759 (last visited Jan 27, 2021).
As a result of what this Court has declared as ambiguous language in 21 U.S.C.
§841 and 21 C.F.R. §1306.04, physicians in the United States are being convicted for
professional disagreements and violations of the “standard of care” when prescribing
opioids. United States v. Moore, 423 U.S. 122, 135; 96 S. Ct. 335, 345 (1975). The
Circuits are widely split on their interpretation of 21 U.S.C. §841 and 21 C.F.R.
§1306.04 and it is time for this Court to revisit United States v. Moore.
Petitioner-Appellant, George P. Naum III was convicted of violations of 21
U.S.C. §841(a)(l) and 21 U.S.C. §846 for prescribing Suboxone, a drug used to treat
opioid use disorder. The central issue at trial was his use of nurses to expand the
availability of patient care consistent with SAMHSA regulations. At trial, the trial
court held that the elements of 21 U.S.C. §841(a)(l) as applied to a physician can be
applied in the disjunctive thereby permitting the Government to proceed on a theory
that prescriptions were issued either “beyond the bounds of professional practice” or
l
“for other than a legitimate medical purpose.” This permitted the Government to
prosecute and convict Dr. Naum solely for violating professional standards. Further,
the trial court prohibited expert testimony regarding the medical legitimacy of the
prescriptions and hospital programs that operated in the same manner as Defendant.
The question presented is: Can the elements of 21 U.S.C. §841(a)(l) as defined
in United States v. Moore, 423 U.S. 122 (1975) requiring the Government to prove
unlawful distribution of a controlled substance “outside the usual course of
professional practice” and “for other than a legitimate medical purpose” be applied in
the disjunctive permitting the Government to prove only that a prescription was
prescribed “outside the usual course of professional practice” or “outside the bounds
of professional practice” solely for violation of a professional standard without regard
to the medical legitimacy of the medication?
li
LIST OF PARTIES
All parties to the proceeding are identified in the style of the case.
m
CORPORATE DISCLOSURE STATEMENT
Pursuant to Supreme Court Rule 29.6, Petitioner-Appellant, George P. Naum
IIP discloses the following. There is no parent or publicly held company owning 10%
or more of Petitioner-Appellant’s stock.
IV
LIST OF PROCEEDINGS
Trial Court
United States of America, Plaintiff, v. George P. Naum III, Defendant
United States District Court for the Northern District of West Virginia
Case No.: l:18-cr-00001
Date of Judgment: February 11, 2020
Direct Appeal
United States of America, Plaintiff-Appellee, v. George P. Naum III, DefendantAppellant
United States Court of Appeals for the Fourth Circuit
Case No.: 20-4133
Date of Judgment: October 13, 2020
Petition for Rehearing and Rehearing En Banc
United States of America, Plaintiff-Appellee, v. George P. Naum III, DefendantAppellant
United States Court of Appeals for the Fourth Circuit
Case No.: 20-4133
Date of Judgment: November 24, 2020
v
TABLE OF CONTENTS
QUESTION PRESENTED FOR REVIEW.......................................
l
LIST OF PARTIES................................................... ..........................
m
CORPORATE DISCLOSURE STATEMENT..................................
IV
LIST OF PROCEEDINGS..................................................................
v
TABLE OF CONTENTS......................................................................
VI
TABLE OF AUTHORITIES...............................................................
Vlll
PETITION FOR A WRIT OF CERTIORARI...................................
1
OPINION BELOW................................................................................
1
JURISDICTION....................................................................................
1
STATUTES, ORDINANCES AND REGULATIONS INVOLVED
1
STATEMENT........................................................................................
3
REASONS FOR GRANTING THE PETITION...............................
11
A.
The Fourth Circuit has decided an important federal question in a way that
11
conflicts with this Court’s holdings in Moore and Gonzales
a.
Overview................................................................................................................ 11
b. Circuit Court interpretations of Moore have shifted significantly since the
decision.......................................................................................................................... 12
c. The Fourth Circuit’s holding in Naum is not grounded in the CSA, Moore,
OR Gonzales, creating further ambiguity disruptive to the state’s right to
regulate the practice of medicine............................................................................... 17
d. Various Circuits have interpreted the vague language of 21 U.S.C.
§841(a)(l) and 21 C.F.R. §1306.04 to permit physicians to be prosecuted for
professional disagreements, which has a dangerous impact on medical
advancement................................................................................................................. 23
e. There is no generally accepted standard for prescribing controlled
substances in the U.S.................................................................................................. 31
CONCLUSION....................................
35
CERTIFICATE OF WORD COUNT
36
PROOF OF SERVICE.......................
37
vi
INDEX TO APPENDIX
Unpublished Per Curium Opinion of the Fourth Circuit Court of Appeals, October 13,
A1
2020
Opinion in United States v. Naum, 2020 U.S. App. LEXIS 32248 (4th Cir. 2020)
A19
Order Denying Petition for Rehearing and Rehearing En Banc, November 24, 2020
A28
Order in United States v. Naum, 2020 U.S. App. LEXIS 37150 (4th Cir. 2020)
A29
Judgment in a Criminal Case, Northern District of West Virginia, February 11, 2020
A30
Transcript, Testimony of Dr. Standiford Helm II,
A3 8
United States’ Motion in Limine on Standards of Governing Prescriptions for
Suboxone [ECF No. 166]
A93
United States’ Motion in Limine [ECF No. 273]
A768
Order Following Motion Hearing [ECF No. 299]
AHA
Vll
TABLE OF AUTHORITIES
Cases
Gonzales v. Oregon, 56 U.S. 243, 271 (2006)....... .
4, 9, 10, 11, 12, 15, 16, 17, 19, 21, 22, 23, 24, 34
In Re Wesley Pope, M.D., 82 Fed. Reg. 14944 (Drug Enft Admin. Mar. 23, 2017)... 29
United States v. Alerre, 430 F.3d 681 (4th Cir. 2005)
25
United States v. Armstrong, 550 F.3d 382 (5th Cir. 2008)
26
United States v. Bartee, 479 F.3d 484 (10th Cir. 1973)
22
United States v. Birbragher, 576 F. Supp. 2d 1000 (N.D. Iowa 2008)
31
United States v. Brickhouse, No. 3:14-CR-124, 2016 U.S. Dist. LEXIS 59821, 2016
WL 2654359 (E.D. Tenn. Mar. 30, 2016)............... ...................................................... 30
United States v. Chube, 538 F.3d 693 (7th Cir. 2008)
19, 22, 27, 28
United States v. Collier, 478 F.2d 268 (5th Cir. 1973)
30
United States v. Darji, 609 F. App’x 320 (6th Cir. 2015)
30
United States v. Enmon, 686 Fed. Appx. 796 (11th Cir. 2017)
26
United States v. Feingold, 454 F.3d 1001, 1008 (9th Cir. 2006)
19, 22, 28
United States v. Hitzig, 63 Fed. Appx. 83 (4th Cir. 2003)
3, 18
United States v. Hurwitz, 459 F.3d 463 (4th Cir. 2006)
13
United States v. Ignasiak, 667 F.3d 1217 (11th Cir. 2012)
20
United States v. Johnson, 71 F.3d 539 (6th Cir. 1995)
20
United States v. Kholi, 847 F.3d 483 (7th Cir. 2017)
22
United States v. Lague, 971 F.3d 1032 (9th Cir. 2020)
33
United States v. Moore, 423 U.S. 122 (1975)..........................................
i, ii, 4, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19, 21, 22, 23, 24, 28, 31, 34
United States v. Nelson, 383 F.3d, 1227 (10th Cir. 2004)
vm
29, 30
United States v. Newman, No. 3:19-CR-59-TAV-DCP, 2020 U.S. Dist. LEXIS 221891
33
(E.D. Term. Sep. 8, 2020)
United States v. Orta-Rosario, 469 F. App’x 140 (4th Cir. 2012)
30
United States v. Prejean, 429 F. Supp. 2d 782 (E.D. La. 2006)
31
United States v. Quinones, 536 F. Supp. 2d 267 (E.D.N.Y. 2008)
30
United States v. Rosenberg, 585 F.3d 355 (7th Cir. 2009)
19
United States v. Singh, 54 F.3d 1182 (4th Cir. 1995)
10, 11, 17, 19, 20
United States v. Smith, 573 F.3d 639 (8th Cir. 2009)
28, 29
United States v. Tran Trong Cuong, 18 F.3d 1132 (4th Cir. 1994)
10, 11, 17, 20, 25
United States v. Vamos, 797 F.3d 1146 (2nd Cir. 1986)
27
United States v. Volkman, 736 F.3d 1013 (6th Cir. 2013)
27
Statutes
8
18U.S.C. §2
4, 10
21 U.S.C. §801
21 U.S.C. §802(21)
2
21 U.S.C. §802(6)
3
21 U.S.C. §821
13
21 U.S.C. §822(b)
13
21 U.S.C. §823(g)(2)
5 .
21 U.S.C. §841
i, 26, 30
21 U.S.C. §841(a)
21 U.S.C. §841(a)(1)
3, 8, 9, 12, 15, 19, 21, 23, 28
i, ii, 1, 8, 9, 13, 14, 15, 17, 18, 20, 23, 24, 28, 29, 30, 31, 34
21 U.S.C. §846
i, 3, 8
28 U.S.C. §1254(1)
1
42 U.S.C. §290bb-2a
3,4
IX
Rules
32
81 Fed. Reg. 45603
Regulations
21 C.F.R. §1301.01
23
21 C.F.R. §1306.04
i, 2, 3, 23, 24, 29, 30, 31, 34
9, 13, 19, 30
21 C.F.R. §1306.04(a)
42 C.F.R. §8.2
5
42 C.F.R. §8.610
5
Other
American Medical Association, AMA Urges CDC to Revise Opioid Prescribing
Guidelines, June 18, 2020, https://www.ama-assn.org/press-center/pressreleases/ama-urges-cdc-revise-opioid-prescribing-guideline, accessed Jan. 19, 2021
34
Andrew Rosenblum et al., Opioids and the Treatment of Chronic Pain:
Controversies, Current Status, and Future Directions, 16(5) EXP. CLIN.
PSYCHOPHARMACOL, 405 (2018)...............................................................
32
Andy Baker-White, A Look at State Legislation Limiting Opioid Prescriptions,
ASTHO (Feb. 23, 2017), http://www.astho.org/StatePublicHealth/A-Look-at-State33
Legislation-Limiting-Opioid-Prescriptions/2-23-17/
Centers for Disease Control and Prevention, CDC Guidelines for Prescribing
Opioids for Chronic Pain, (last updated Aug. 29, 2017),
https://www.cdc.gov/drugoverdose/prescribing/guideline.html.......................
32
CMS, Advance Notice of Methodological Changes for Calendar Year (CV) 2019 for
Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies
and 2019 Draft Call Letter, (Feb. 1, 2018)
33
Doug Campos-Outcalt, M.D., M.P.A., Opioids for Chronic Pain: The CDC’s 12
Recommendations, 65(12) J. FAM. PRACT. 906-909 (Dec. 2016)....................
33
H.R. Rep. No. 91-1444
4
John J. Mulrooney II & Katherine E. Legel, Current Navigation Points in Drug
Diversion Law: Hidden Rocks in Shallow, Murky, Drug-Infested Waters, 101
Marq. L. Rev. 333 (2017)............................................................................................
29
x
R.K. Portenoy & K.M. Foley, Chronic Use of Opioid Analgesics in Non-Malignant
Pain: Report of 38 Cases, 25(2) PAIN, 171-86 (May 1986).... ................................. 32
xi
PETITION FOR A WRIT OF CERTIORARI
Petitioner-Appellant, Dr. George P. Naum III, respectfully prays that a writ of
certiorari be issued to review the judgment below of the Fourth Circuit Court of
Appeals.
OPINION BELOW
The opinion of the U.S. Court of Appeals for the Fourth Circuit appears in the
Appendix to this Petition and can be found at United States u. Naum, 2020 U.S. App.
LEXIS 32248 (4th Cir. 2020).
JURISDICTION
On October 13, 2020, a three-judge panel of the Fourth Circuit Court of
Appeals entered its opinion in United States v. Naum, 2020 U.S. App. LEXIS 32248
(4th Cir. 2020). Defendant filed a Petition for Panel Rehearing, or alternatively, for
En Banc Rehearing, and this rehearing was denied. United States u. Naum, 2020 U.S.
App. LEXIS 37150 (4th Cir., Nov. 24, 2020). This Court has jurisdiction pursuant to
28 U.S.C. §1254(1).
STATUTES, ORDINANCES AND REGULATIONS INVOLVED
“Except as authorized by this subchapter, it shall be unlawful for any person
knowingly or intentionally ... to manufacture, distribute, or dispense, or possess with
intent to manufacture, distribute, or dispense, a controlled substance . ...” 21 U.S.C.
§841(a)(l).
1
“A prescription for a controlled substance to be effective must be issued for a
legitimate medical purpose by an individual practitioner acting in the usual course of
his professional practice.” 21 C.F.R. §1306.04.
“The term ‘practitioner’ means a physician ... or other person licensed,
registered, or otherwise permitted, by the United States or the jurisdiction in which
he practices ... to distribute, dispense, . . . , administer, or use ... a controlled
substance in the course of professional practice . . . .” 21 U.S.C. §802(21).
2
STATEMENT
Defendant was a registered practitioner with the Drug Enforcement
Administration and authorized to prescribe controlled substances per 21 U.S.C.
§802(6). Defendant was indicted for violations of 21 U.S.C. §841(a) and §846 for
knowingly and willfully distributing and dispensing controlled substances outside the
usual course of medical practice and for other than a legitimate medical purpose.
Prior to trial, the Government filed a motion in limine seeking to clarify its
standard of proof, arguing its burden of proof is to show that Defendant prescribed
controlled substances “for other than a legitimate medical purpose or not within the
bounds of professional practice.” U.S.’s Motion in Limine at 3, United States v. Naum,
No. 18-cr-00001 (N.D. W.Va. filed Apr. 15, 2019), ECF No. 273; see United States v.
Hitzig, 63 Fed. Appx. 83 (4th Cir. 2003). The trial court granted the Government’s
motion. Order Following Motion Hearing, United States v. Naum, No. 18-cr-00001
(N.D. W.Va. filed Apr. 23, 2019), ECF No. 299. The court’s order permitted the
Government to sever the standard outlined in 21 C.F.R. §1306.04 and proceed only
on the theory that Defendant’s prescriptions were issued not within “the bounds of
professional practice.”
Defendant was charged with unlawful distribution of Suboxone. Suboxone is
regulated differently than other medications because it can be used to treat patients
suffering from opioid-use disorder. The Federal Government pre-empted the field of
Opioid Treatment Standards and delegated the creation of treatment standards to
Health and Human Services. 42 U.S.C. §290bb-2a. This statute specifically pre-
3
empted state governance of addiction treatment and the creation of methods of
professional practice. See Gonzales v. Oregon, 56 U.S. 243, 271 (2006) (holding that
42 U.S.C. §290bb-2a is the only area in which Congress set general uniform standards
of medical practice). In Gonzales, the Court noted: “[t]his provision strengthens the
understanding of the CSA [Controlled Substances Act, 21 U.S.C. §801] as a statute
combating recreational drug abuse, and also indicates that when Congress wants to
regulate medical practice in the given scheme, it does so by explicit language in the
statute.” Id. at 272. The reason Congress sought to pre-empt state regulation of
addiction treatment is exactly why the type of prosecution levied against Defendant
should be disfavored for very strong public policy considerations:
The practicing physician has ... been confused as to when he may
prescribe narcotic drugs for an addict. Out of a fear of prosecution many
physicians refuse to use narcotics in the treatment of addicts except
occasionally in a withdrawal regimen lasting no longer than a few
weeks. In most instances they shun addicts as patients.
United States v. Moore, 423 U.S. 122, 143-44 (1975) (internal citations omitted). The
Court found that this Congress-created national standard “was designed to clarify for
the medical profession ... the extent to which they may safely go into treating narcotic
addicts as patients.” Id. at 144 (quoting H.R. Rep. No. 91-1444, at 14). Under this
scheme, “[t]hose physicians who comply with the recommendations made by the
Secretary will no longer jeopardize their professional careers ... .” Id. (quoting H.R.
Rep. No. 91-1444, at 15).
Traditionally, patients could only be treated for addiction in a traditional
“methadone clinic setting.” However, in 2000, providers were permitted to treat
patients in an office-based setting but were required to obtain a separate DEA
4
registration in accordance with 21 U.S.C. §823(g)(2). In an effort to expand addiction
treatment and make it more widely available to areas suffering from the opioid
epidemic, the Federal Government later increased patients’ limit from 100 to 275. 42
C.F.R. §8.610 and 42 C.F.R. §8.2.
Given the unique application of medications like Suboxone for treating
addiction, and to aid providers in how they may safely expand their reach to treat
addiction medicine patients, the Substance Abuse and Mental Health Services
Administration (“SAMHSA”) created publications and training designed to assist
doctors with “best practices.” Unlike traditional medicine, nurses play a larger role
in medication-assisted therapy so that patients can receive more access to care.
Exhibit 2 to United States’ Motion in Limine on Standards Governing Prescriptions
for Suboxone at 41, United States v. Naum, No. 18-cr-00001 (N.D. W.Va. filed Jan.
29, 2019), ECF No. 166-2. In its 140-page guide for assisting nurses in this new role,
SAMHSA permitted a nurse to perform all follow-up care and relapse prevention
functions. Id. (“Nurses must continuously monitor urine drug testing or other
toxicology testing, the number of pills in the patient’s supply, medication dosage, and
pharmacy checks to help prevent relapse”).
At trial, Defendant called Dr. Sandiford Helm, a board-certified addiction
medicine and pain management physician and past president of the American Society
of Interventional Pain Physicians. Helm testified that Suboxone is a drug designed
to block the effects of opioid withdrawal; patients suffering from opioid use disorder
should be put on a long-term, stable dose of Suboxone indefinitely until patient and
5
provider agree the patient is ready to “wean” off it. A central issue at trial was
Defendant’s using a registered nurse to see patients after initial induction and to
refill prescriptions for Suboxone without Defendant’s presence. Defendant would
review the treatment of each patient and provide notes for subsequent follow-up,
instructing the nurse to increase, decrease, or keep the dose the same upon next visit.
Helm testified that after a patient has seen a provider for initial intake, subsequent
monitoring and follow-up can be delegated to nurses, but the physician must
determine how much medication the patient gets. Transcript of Trial Testimony by
Dr. Standiford Helm at 14, United States v. Naum, No. 18-cr-00001 (N.D. W.Va. Apr.
29, 2019). Helm described Defendant’s process: “The nurse would go in and perform
the follow-up exam and — as I described it, and get the appropriate monitoring and
then would issue the prescription, based upon the previous order provided by the
physician.” Id. at 24.
Helm testified that he believed Defendant established a physician-patient
relationship with patients treated at his clinic during initial intake, and it was
medically appropriate to assign follow-up care to a nurse under SAMHSA Guidelines.
Id. at 19. He also testified that Defendant ensured compliance and properly prevented
diversion in accordance with “best practices” by requiring frequent urinalysis tests
and prescription drug monitoring report checks. Id. at 21. Helm opined it being
permissible for a physician to simply review the care of a nurse in a Suboxone
program by signing off on the charts. Id. at 23.
6
Helm was then asked by Defendant’s counsel if he had seen other examples of
Defendant’s treatment model being used, which was met by the trial court’s sua
sponte objection. Id. at 27. In a subsequent sidebar proceeding, the court refused to
permit Helm to testify about a model similar to the treatment model used by
Defendant, permitting nurses to treat patients upon follow-up and call-in physicianissued medication orders. “And to the extent that there are other models out there
that are not relevant to this because they’ve been permitted by special regulation in
the states and are funded by state funds, that is not this model. It will confuse the
jury. We are not doing it.” Id. at 27.
After preventing Defendant from introducing evidence about a state-funded
model permitting nurses to provide follow-up care (in accordance with SAMHSA
guidelines) and call-in prescriptions, the court, sua sponte, instructed the jury as
follows:
Ladies and gentlemen, I just want to make clear to you that we’ve
had a discussion at the bench about anticipated testimony from Dr.
Helm regarding a state-approved and funded model in Massachusetts
that is a very different approach protocol-wise in the office, and,
actually, in the kind of team put together, than what was utilized at
Advance Healthcare. That doesn’t mean one is right and one is wrong.
But it’s been my prior ruling in this case, and during this case, that that
is — that model is not a relevant discussion to what happened here and
the questions that are before you here.
Id. at 27-28.
Later during testimony, Helm began to explain that a prescription for a
particular patient was written in the bounds of professional practice because the
patient had a legitimate medical need. Prosecution objected, saying the Government
7
need only prove a prescription was written “outside the bounds of professional
practice” and therefore the medical legitimacy of the prescription is not relevant. Id.
at 37. In open court, the trial judge stated:
I don’t think the question of whether it was for a legitimate medical
practice has ever been raised by the Government. It’s not part of the
case-in-chief. And it’s not an issue in this case and, therefore, is not
helpful to the jury in determining the issues in the case. So his opinion
is, it’s not outside the bounds of medical practice. You asked him why.
He’s explaining. And that’s that.
After excluding the medical purpose of a medication from the inquiry into
whether a prescription was issued “in the bounds of professional practice,” the court
offered no guidance about its definition of “bounds of professional practice.”
The jury convicted Defendant of conspiracy to distribute Suboxone “outside the
bounds of professional medical practice” from 2008-2016 in violation of 21 U.S.C.
§841(a)(l) and §846, and four counts of aiding and abetting distribution of Suboxone
outside the bounds of professional medical practice in violation of 21 U.S.C. §841(a)
and 18 U.S.C. §2. The court sentenced Defendant to six months’ incarceration
followed by six months’ home detention.
Section 841(a) of Title 21 of the U.S. Code provides, in relevant part: “(a) ... it
shall be unlawful for any person knowingly or intentionally — (1) to ... distribute, ...
a controlled substance ....” 21 U.S.C. §841(a)(l). Thus, to secure a conviction under
this section, the Government must prove beyond a reasonable doubt that a defendant
knowingly or intentionally distributed the controlled substance alleged in the
indictment, and at the time of such distribution, the defendant knew the substance
distributed was a controlled substance under the law. There is no dispute that the
8
prescriptions written by Defendant were controlled substances under the CSA and
therefore could not be lawfully distributed other than as provided by law.
In 1971, the Attorney General promulgated a regulation requiring every
controlled substance prescription “be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional practice.” See
Gonzales (citing 21 C.F.R. § 1306.04(a) (2005)). In 1975, this Court gave its only
guidance on what it means for a practice to issue a prescription for a legitimate
medical purpose in the usual course of professional practice: “the scheme of the [CSA],
viewed against the background of the legislative history reveals an intent to limit a
registered physician’s dispensing authority to the course of his ‘professional
practice.’” Moore, 423 U.S. at 140. Therefore, a licensed physician who prescribes
controlled substances outside the bounds of his professional medical practice is
subject to prosecution and is no different than “a large-scale ‘pusher.’” Id. at 143. The
Moore court was careful to emphasize that Moore had so wantonly ignored the basic
protocols of the medical profession, “he acted as a large-scale ‘pusher’ — not as a
physician.” Id. The court further described §841(a) as prohibiting “the significantly
greater offense of acting as a drug ‘pusher.’” Id. at 138. These statements show that
the Moore court based its decision not merely on the fact that a doctor committed
malpractice, or even intentional malpractice, but rather that his actions betrayed any
semblance of legitimate medical treatment.
The only other opportunity this Court has had to analyze the conduct required
of a physician to be convicted of a violation of 21 U.S.C. §841(a)(l) mirrored the
9
language of Moore, again emphasizing that Federal Jurisdiction under the CSA is not
triggered upon a showing of malpractice, which is left up to the states. Gonzales. In
explaining that the CSA did not authorize the U.S. Attorney General to bar
dispensation of controlled substances for assisted suicide in the face of a state medical
regime permitting such conduct, this Court said:
The Controlled Substances Act (CSA), 21 U.S.C. §801 et seq., and case
law amply support the conclusion that Congress regulates medical
practice insofar as it bars doctors from using their prescription-writing
powers as a means to engage in illicit drug dealing and trafficking as
conventionally understood. Beyond this, however, the statute manifests
no intent to regulate the practice of medicine generally.
Gonzales, 546 U.S. at 269-70.
Since Moore and Gonzales, Circuit decisions have varied widely in interpreting
the limited language in both cases. In the instant case, the Fourth Circuit upheld the
trial court’s ruling that prevented Defendant from presenting evidence that his
treatment of patients was “for a legitimate medical purpose.” Naum at *11. The
Fourth Circuit held that the “Government may meet its burden by establishing that
the physician’s actions were not for legitimate medical purposes in the usual course
of professional medical practice or were beyond the bounds of professional medical
practice.” Naum at *10. United States v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995); see
also United States v. Tran Trong Cuong, 18 F.3d 1132, 1141 (4th Cir. 1994). The
Fourth Circuit also held that the Government is not required to prove “both prongs”
(i.e., no legitimate purpose and beyond the bounds of medical practice). The court
conceded that Defendant’s treatment was for a legitimate medical purpose: “there
was no dispute at trial that Naum’s patients suffered from addiction and required
10
treatment.” Naum at 11. The Fourth Circuit therefore presumes the possibility for a
physician to prescribe a medication for a “legitimate medical purpose” but still
“beyond the bounds of professional medical practice.” Id.
In the instant case, the Fourth Circuit did not further explain the meaning of
“beyond the bounds of professional medical practice” and why that standard can be
met without analyzing whether there was a legitimate medical purpose for a
prescription. Its cited cases (Singh, Tran Trong Cuong) do not shed light on the
Fourth Circuit’s holding that a physician can be held criminally liable for a medically
appropriate prescription other than: “there are no specific guidelines concerning what
is required to support a conclusion that an accused acted outside the usual course of
professional practice.” Singh at 1187. Tran Trong Cuong. Without sufficient
explanation in prior Fourth Circuit holdings, the only reasonable conclusion is that
the Fourth Circuit interprets “bounds of professional practice” to reference
professional norms the medical community generally accepts. This is in direct conflict
with two holdings of this Court and several circuits. Moreover, such a holding
expands the CSA’s prohibition on unlawful prescribing to questions of the quality or
legitimacy of medical treatment which, per Gonzales, is outside the CSA’s purview.
Gonzales at 269-70.
REASONS FOR GRANTING THE PETITION
A. The Fourth Circuit has decided an important federal question in a
way that conflicts with this Court’s holdings in Moore and Gonzales.
a. Overview
11
Per the Fourth Circuit, a physician can be convicted of unlawful distribution
even where both the Government and this Court concede that the prescription was
issued for a legitimate medical purpose. United States v. Naum, 2020 U.S. App.
LEXIS 32248 at *11 (4th Cir. 2020). The court permitted the Government to prove
only that Defendant’s prescriptions were “beyond the bounds of professional medical
practice.” Id. However, the Fourth Circuit did not explain how a prescription issued
by a physician can be for a legitimate medical purpose but still outside the bounds of
medical practice. A common sense reading of the opinion suggests that the Fourth
Circuit interprets “outside the bounds of professional medical practice” as conduct
violating a medical standard. Such a holding exceeds the CSA’s intent and preempts
states’ rights to regulate the practice of medicine. “It comes as little surprise, then,
that we have not considered the extent to which the CSA regulates medical practice
beyond prohibiting a doctor from acting as a drug pusher instead of a physician.”
Gonzales.
b. Circuit Court interpretations of Moore have shifted significantly
since the decision
Under 21 U.S.C. §841(a), “[e]xcept as authorized by this subchapter, it shall be
unlawful for any person knowingly or intentionally (1) to manufacture distribute or
dispense or possess with intent to manufacture, distribute, or dispense, a controlled
substance....” In order to permit controlled substances to be used when appropriate,
the Attorney General may “promulgate rules and regulations ... relating to the
12
registration and control of the manufacture, distribution and dispensing of controlled
substances
21 U.S.C. §821.
Doctors “registered” by the Attorney General are authorized to write controlled
substance prescriptions so long as they comply with registration requirements. 21
U.S.C. §822(b); United States v. Hurwitz, 459 F.3d 463, 475 (4th Cir. 2006). Pursuant
to 21 U.S.C. §821, the Attorney General adopted 21 C.F.R. §1306.04(a): “A
prescription for controlled substances to be effective must be issued for a legitimate
medical purpose by an individual practitioner acting in the usual course of his
professional practice.”
The only case decided by this Court in the CSA’s 40-year existence directly
interpreting the standard under 21 U.S.C. §841(a)(l) is Moore. Moore was charged in
a 639-count indictment alleging that he knowingly distributed methadone in violation
of 21 U.S.C. §841(a)(l). He contended that the CSA prohibition on unlawful
distribution and the severe penalties associated with distribution cannot be applied
to physicians. Id. at 126. Instead, he argued, the provision of the CSA prohibiting
“technical” violations is the provision Congress intended to apply to physicians. Id.
The Government argued that §841(a)(l) applies to physicians when they prescribe
“without any medical justification at all.” Id. at 138. At oral argument, Justice Potter
Stewart was quick to note that prosecuting physicians based on professional
disagreements rests on dubious grounds when the government bases a prescription’s
legitimacy on whether the practice is generally accepted. Id. Oral Argument in Moore,
Oyez, https://www.oyez.org/cases/1975/74-759 (last visited Jan. 27, 2021). This Court
13
held that Moore could be prosecuted under 21 U.S.C. §841(a)(l) because he was not
acting in any way as a physician but instead was a large-scale drug “‘pusher.’” Id.
In deciding that 21 U.S.C. §841(a)(l) could be applied to physicians, this Court
was clear to recognize that Moore could be subject to criminal liability, not for
violating a standard of care, but because he ceased becoming a physician at all. It is
here where this Court first used the phrase “bounds of professional practice” and used
it to demark the line between the practice of medicine and unlawful drug dealing.
Particularly important to this Court’s decision: the CSA was created to prevent
distribution to illegitimate channels, i.e., “drug diversion.” Id. at 135-36. “The
legislative history indicates that congress was concerned with the nature of the drug
transaction, rather than with the status of the defendant.” Id. at 134. Both bills and
committee reports show that the CSA’s prohibition on unlawful dispensing and
prescribing was to ensure that drugs are only prescribed and dispensed within the
legitimate distribution chain. Id. As such, the potential for diversion from this
legitimate distribution chain weighed heavily in this Court’s decision to hold that a
physician could be prosecuted for a violation of 21 U.S.C. §841(a)(l). “Although this
language is ambiguous, the most sensible interpretation is that the penalty to be
imposed for a violation was intended to turn on whether the transaction falls within
or without legitimate channels.” Id. at 135.
The Moore Court specifically avoided the notion that a violation of medical
practice guidelines or standards could form the per se basis of a conviction under 21
U.S.C. §841(a)(l).
14
However, that is not to say that violations of medical practice guidelines,
standards of care, or even state regulations constitute per se violation of 21 U.S.C.
§841(a). Congress was concerned about unlawful drug diversion, not with enforcing
medical standards, which is left solely to the states. Id. at 135.
Congress regulates medical practice insofar as it bars doctors from using
their prescription-writing powers as a means to engage in illicit drug
dealing and trafficking as conventionally understood. Beyond this,
however, the statute manifests no intent to regulate the practice of
medicine generally. The silence is understandable given the structure
and limitations of federalism, which allow the States great latitude
under their police powers to legislate as to the protection of the lives,
limbs, health, comfort, and quiet of all persons.
Gonzales.
In Moore, this Court refused to permit federal courts to be medical standards
enforcers. In the only other case addressing the CSA’s scope, this Court reiterated
Moore’s language and again held that a physician only runs afoul of the CSA when
he/she ceases being a physician. In Gonzales, this Court addressed whether the
Attorney General could issue a regulation declaring the Oregon Death with Dignity
Act a violation of the CSA and 21 U.S.C. §841(a)(l). In holding that the CSA cannot
be used to enforce standards of practice, this Court maintained that the CSA
explicitly contemplates a role for the states in regulating controlled substances as
evidenced by its preemption provision: “No provision of this subchapter shall be
construed as indicating an intent on the part of the Congress to occupy the field in
which that provision operates ... to the exclusion of any State law on the same subject
matter which would otherwise be within the authority or the State.” Id. at 251.
15
In Gonzales, this Court again clarified that the CSA cannot apply to
prescriptions issued for a medical purpose: “[It] allows prescription drugs only if they
have a ‘currently accepted medical use.’” However, the Court noted that “legitimate
medical purpose” is a generality susceptible to more precise definition and open to
varying constructions and thus ambiguous. Id. at 258. Regardless, this Court
determined that the statute cannot be interpreted to attempt to define standards of
medical practice: “[t]he structure of the CSA, then, conveys unwillingness to cede
medical judgments to an Executive official who lacks medical expertise.” Id. This
court was concerned that if the Attorney General had the authority to declare the use
of a particular drug, “he could decide whether any particular drug may be used for
any particular purpose, or indeed whether a physician who administers any
controversial treatment could be deregistered.” Id. at 268.
After clarifying that the CSA cannot be interpreted as regulating the practice
of medicine generally or permitting the Attorney General to create a “standard of
care,” the Gonzales Court re-affirmed its Moore holding: the CSA does not regulate
the “medical practice beyond prohibiting a doctor from acting as a drug ‘pusher’
instead of a physician.” Id. at 269.
The statute and our case law amply support the [*270] conclusion
that Congress regulates medical practice insofar as it bars doctors from
using their prescription-writing powers as a means to engage in illicit
drug dealing and trafficking as conventionally understood. Beyond this,
however, the statute manifests no intent to regulate the practice of
medicine generally. The silence is understandable given the structure
and limitations of federalism, which allow the States “great latitude
under their police powers to legislate as to the protection of the lives,
limbs, health, comfort, and quiet of all persons.”
16
Gonzales.
Since Gonzales, Circuits have split widely in interpreting 21 U.S.C. §841(a)(l)’s
ambiguous language and its accompanying regulations. In the instant case, the
Fourth Circuit determined that “legitimate medical purpose” and “bounds of
professional practice” carry two different meanings, creating a dual standard from
which the prosecution can pick a theory. Naum at 11.
c. The Fourth Circuit’s holding in Naum, is not grounded in the
CSA, Moore, OR Gonzales, creating further ambiguity disruptive
to the state’s right to regulate the practice of medicine
In the instant case, the Fourth Circuit determined that “legitimate medical
purpose” and “bounds of professional practice” creates a disjunctive standard from
which the prosecution may convict on either theory. Naum at 11. Moreover, the panel
determined that if the prosecution chooses the “bounds of professional practice”
standard, the medication’s medical purpose is irrelevant. Naum at 11. The Fourth
Circuit does not: define “bounds of professional practice;” define how it is different
from “legitimate medical purpose;” or state how the medical need for a particular
medication is irrelevant to that analysis.
In its motion in limine, the Government argued that per the standards set forth
in Singh and Tran Trong Cuong, it need not prove lack of “legitimate medical
purpose.” It tied its argument to the holdings in both cases that the Government is
not required to prove that the physician acted with improper purpose: “In sum,
although the testimony does not adduce compelling evidence that [the defendant]
17
prescribed with malicious motive or desire to make a profit, those motivations, though
common in 841(a)(1) prosecutions are not required to convict.” U.S.’s Motion in
Limine at 3, United States v. Naum, No. 18-cr-00001 (N.D. W.Va. filed Apr. 15, 2019),
ECF No. 273. While Fourth Circuit caselaw does suggest that the Government is not
required to prove motive or improper purpose in an §841(a)(l) prosecution, that court
has never held that the medical purpose for the prescription is irrelevant, and the
burden of proof can be satisfied by showing that a prescription was either for other
than a legitimate medical purpose or outside the bounds of professional practice.
United States v. Hitzig, 63 Fed. Appx. 83 (4th Cir. 2003).
The language the Government cited in its motion in limine did not authorize
it to sever the standard and pick whichever one it wished to prove:
Our precedent makes it clear that the standard for criminal liability
is that the physician’s conduct in dispensing a controlled substance “falls
outside the boundaries of the physicians professional practice.” While
the government may meet its burden of proving guilt by showing that a
physician dispensed a controlled substance for an illegitimate purpose,
the government is not required to make such a showing.
Id. at 86.
In affirming the trial court’s decision, the Fourth Circuit, for the first time and
in an unpublished opinion, stated: “the Government is not required to prove both
prongs (i.e., no legitimate purpose and beyond professional bounds), and therefore,
there was no error in permitting the Government to proceed only on the theory that
Naum’s actions were beyond the bounds of professional medical practice. See Singh,
54 F.3d at 1188.” Unpublished Per Curiam Opinion at 9, United States v. Naum, No.
20-4133 (4th Cir. filed October 13, 2020), ECF No. 31. The Fourth Circuit did not
18
explain how, under Moore and Gonzales, it is possible for a physician’s prescription
to be issued for a legitimate medical purpose but outside the bounds of medical
practice.
The problem in the instant case lies with the Fourth Circuit’s formulation of
the third element. The first portion of this element draws directly from the language
of 21 C.F.R. § 1306.04(a) and is not problematic. The second portion (“or [the
defendant’s actions] were beyond the bounds of medical practice”), however, takes the
second element required by the regulation, separates it from the first, and permits a
jury to convict based upon a finding of that element alone.
Other courts formulate the requirements in harmony with 21 C.F.R.
§ 1306.04(a), imposing a conjunctive duty on the prosecution, and hold that the
Government must establish that each prescription was dispensed without a
legitimate medical purpose and outside the usual course of medical practice. See, e.g.,
United States v. Rosenberg, 585 F.3d 355, 357 (7th Cir. 2009) (“In order for a
prescription to be unlawful it must not have a legitimate medical purpose and must
be dispensed outside the usual course of medical practice;” United States v. Chube,
538 F.3d 693, 701 (7th Cir. 2008) (same); United States v. Feingold, 454 F.3d 1001,
1008 (9th Cir. 2006) (“[T]o convict a practitioner under 841(a), the government must
prove ... that the distribution of those controlled substances was outside the usual
course of professional practice and without a legitimate medical purpose”); United
States v. Johnson, 71 F.3d 539, 542 (6th Cir. 1995) (“In order to obtain a conviction
under 21 U.S.C. 841(a)(1) against a licensed physician ... the government must show:
19
... [t]hat defendant prescribed the drug without a legitimate medical purpose and
outside the course of professional practice”). The Eleventh Circuit uses a formulation
of the Government’s burden that eliminates the problem entirely by closely tracking
the language of the regulation and not including additional verbiage. See United
States v. Ignasiak, 667 F.3d 1217, 1228 (11th Cir. 2012).
The error in this case was compounded by the District Court’s preventing
Defendant from introducing evidence that patients were seeking treatment for
legitimate purposes: treatment for their addiction. As such, the court prevented
Defendant from presenting evidence that the prescriptions were for a “legitimate
medical purpose,” relying on the Fourth Circuit Court’s precedent in Singh and Tran
Trong Cuong. In upholding the trial court’s determination, the panel ruled: “[t]he
Government is not required to prove both prongs (i.e., no legitimate purpose and
beyond professional bounds), and therefore, there was no error in permitting the
Government to proceed only on the theory that Naum’s actions were beyond the
bounds of professional medical practice.” Unpublished Per Curiam Opinion at 9,
United States u. Naum, No. 20-4133 (4th Cir. filed October 13, 2020), ECF No. 31. The
error with this decision is that it ignores Supreme Court precedent stating that the
standard is not conjunctive or disjunctive, but is one single standard that cannot be
split into two meanings.
The Moore Court clearly articulated that the meaning behind “bounds of
professional practice” is merely another way of stating “for a legitimate medical
purpose in the course of professional practice”:
20
The evidence presented at trial was sufficient for the jury to find that
respondent’s conduct exceeded the bounds of “professional practice.” As
detailed above, he gave inadequate physical examinations or none at all.
He ignored the results of the tests he did make. He did not give
methadone at the clinic and took no precautions against its misuse and
diversion. He did not regulate the dosage at all, prescribing as much and
as frequently as the patient demanded. He did not charge for medical
services rendered, but graduated his fee according to the number of
tablets desired. In practical effect, he acted as a large-scale “pusher” —
not as a physician.
Id. (emphasis added).
It was critical that Moore “acted as a large-scale ‘pusher’ — not as a physician.”
Id. Thus, when a physician ceases acting as a physician (i.e., acts “outside the bounds
of medical practice”), he engages in an unlawful drug transaction akin to a “pusher”
and no different than a corner drug dealer. The only other opportunity this Court has
had to evaluate the standard under 21 U.S.C. §841(a) was in Gonzales, where it
repeated Moore: “it comes as little surprise, then, that we have not considered the
extent to which the CSA regulates medical practice beyond prohibiting a doctor from
acting as a drug ‘pusher’ instead of a physician.” Id. The Court’s message is clear: the
Federal Government does not have authority to regulate the way in which a physician
practices medicine, only whether the physician is seeking to practice medicine or
engage in drug dealer:
Congress regulates medical practice insofar as it bars doctors from
using their prescription-writing powers as a means to engage in illicit
drug dealing and trafficking as conventionally understood. Beyond this,
however, the statute manifests no intent to regulate the practice of
medicine generally. The silence is understandable given the structure
and limitations of federalism, which allow the States “great latitude
under their police powers to legislate as to the protection of the lives,
limbs, health, comfort, and quiet of all persons.”
21
Id. at 270.
Moore and Gonzales emphasize that Defendant can only be convicted if he
stepped away from the practice of medicine and began trafficking in narcotics. It is
not sufficient to show that he failed to adhere to a specific standard of practice. Thus,
it is supremely relevant whether the practice’s patients endeavored to seek medical
treatment or engage in an unlawful transaction for buprenorphine. Moore requires
the Government to prove not that the physician violated some sort of practice
standard, as the Fourth Circuit has held, but that he/she abandoned the practice of
medicine by prescribing medication that lacked a legitimate medical purpose.
Here, the Fourth Circuit’s conclusion that the standard “not for a legitimate
medical purpose in the course of professional medical practice or beyond the bounds
of medical practice” can be split. That a defendant can be precluded from introducing
evidence of the medical purpose of his prescription contradicts Moore and cannot
stand. The standard is one single standard, and to meet its burden the Government
must prove that the physician acted outside the usual course of professional practice
and not for a legitimate medical purpose. Feingold; Chube; United States v. Kholi,
847 F.3d 483, 491 (7th Cir. 2017); United States v. Bartee, 479 F.3d 484, 488 (10th Cir.
1973).
Despite this Court’s clear holding in Gonzales, that the CSA cannot be used as
a tool to regulate the practice of medicine and only criminalizes conduct of those who
exceed the bounds of practice, there is a split of authority as to the proper elements
under 21 U.S.C. §841(a) that this Court must resolve.
22
d. Various Circuits have interpreted the vague language of 21
U.S.C. §841(a)(l) and 21 C.F.R. §1306.04 to permit physicians to
be prosecuted for professional disagreements, which has a
dangerous impact on medical advancement
Despite nearly 100 years of controlled substance jurisprudence, courts are still
split and often confused about the standard of evidence required to convict a
practitioner1 of prescribing controlled substance unlawfully. Since this Court’s
decision in Moore, finding that a doctor can be convicted as a drug trafficker under
§841(a)(l) for unlawfully prescribing controlled substances, federal circuits have
shifted to interpret §841(a)(l) as not prohibiting the non-medical prescribing of drugs,
but rather a deviation from a medical standard. Such a shift presents a danger to the
medical community as a whole, which must now ensure that its conduct adheres to
unclear, wildly shifting professional norms in the emerging pain management field.
Despite this Court’s seemingly clear direction as to the limits of federal power when
prosecuting physicians for prescribing decisions, many courts have begun to apply a
“national standard of care” analysis to physician prescribing cases.
It is necessary for this Court to weigh in and reaffirm Gonzales and Moore to
prevent an abuse of federal power in regulating the practice of medicine. The Circuit
1 The term “practitioner” is used to describe any health professional with prescriptive
authority as defined by 21 C.F.R. §1301.01. This includes physicians, nurse
practitioners, physician assistants, veterinarians, dentists, and any other health
professional or entity granted the ability to issue a prescription for controlled
substances. A split in the Circuits has far-reaching implications for the practice of
various healthcare professions.
23
shift in interpreting Moore, 21 U.S.C. §841(a)(l), and 21 C.F.R. §1306.04 expands
prosecutions under Moore in a way this Court specifically rejected in Gonzales, which
explicitly holds that the CSA’s powers cannot be used to regulate the practice of
medicine. Gonzales.
Prophetically, Justice Stewart in Moore was concerned that an expansion of
the limits of federal power to regulate the practice of medicine would prevent progress
in the medical field:
And is it not true that historically most, if not all of the great
breakthroughs and advances in medical science are made by people who
did not follow the conventional way of doing things. They followed a new
way, their way, and most of the conventional physicians of their day
would have disagreed with them because this is not the way it has
always been done. ... [I]t bothers me that this kind of evidence ... is the
basis for criminal liability. This man was a physician, he was not a
fraud.
United States v. Moore, Oyez, https://www.oyez.org/cases/1975/74-759 (last visited
Jan. 27, 2021).
In the instant case, the Fourth Circuit held that a physician can be convicted
for prescribing “outside the bounds of professional practice” even if the medication
prescribed is for a legitimate medical purpose. Naum at 11. The Fourth Circuit was
silent on its “beyond the bounds of professional practice” interpretation and whether
such a phrase does not include an inquiry into the medical purpose of the medication.
Yet, in its opinion, the Fourth Circuit faulted Defendant for failing to adhere to West
Virginia Board of Medicine requirements as evidence of practice outside the bounds
of professional practice. By eliminating the inquiry into the medical purpose of a
medication and permitting a jury to convict based on violations of medical board
24
rules, the Fourth Circuit appears to interpret the phrase “beyond the bounds of
professional practice” as requiring a physician to adhere to a standard of practice
generally accepted in the community.
Prior to Naum, the Fourth Circuit struck a much different tone than its
previous opinions in United States v. Alerre and Tran Trong Cuong. United States v.
Alerre, 430 F.3d 681 (4th Cir. 2005); Tran Trong Cuong, 18 F.3d at 1133. In both cases,
the Fourth Circuit held that a physician is acting “outside the bounds of professional
medical practice when the authority to prescribe is being used not for the treatment
of a patient but for the purpose of assisting another in the maintenance of a drug
habit or of dispensing controlled substances for other than a legitimate medical
purpose i.e. the personal profit of a physician.” Although the Fourth Circuit’s prior
interpretation of the phrase “beyond the bounds of medical practice” included an
analysis of the medical purpose of the drug, the Fourth Circuit’s opinion in Naum
was not published and did not seek to overturn prior ruling. En banc hearing to
resolve this conflict was denied. United States v. Naum, No. 20-4133, 2020 U.S. App.
LEXIS 37150, at *1 (4th Cir. Nov. 24, 2020).
The Fifth Circuit also holds that a physician may be convicted for violations of
professional standards. In United States v. Armstrong, the court upheld a jury
instruction providing:
A controlled substance is prescribed by a physician in the usual
course of professional practice, and therefore, lawfully, if the substance
is prescribed by him or her in good faith, medically treating a patient in
accordance with the standard of medical practice generally recognized
and accepted in the United States.
25
United States v. Armstrong, 550 F.3d 382 (5th Cir. 2008).
In essence, the Fifth Circuit held that a provider who deviates from the
standard of care is in violation of §841. Id.
Similarly, the Eleventh Circuit upheld a jury instruction in United States v.
Enmon, permitting the jury to find the defendant guilty of an §841 violation if his
conduct did not comport with “generally recognized” standards of medical practice.
United States v. Enmon, 686 Fed. Appx. 796 (11th Cir. 2017), cert denied, 2017 U.S.
LEXIS 5460 (U.S., Oct. 2, 2017). The instruction specifically stated, “[wjhether the
Defendant acted outside the usual course of professional practice is to be judged
objectively by reference to the standards of medical practice generally recognized and
accepted in the United States.” Id. Therefore, “whether the Defendant had a good
faith belief that he dispensed a controlled substance in the usual course of his
professional practice is irrelevant.” Id. at 774. In Enmon, the Eleventh Circuit went
one step further and declared “good faith” medical practice that does not conform to
generally accepted standards of practice as unlawful.
In the Second Circuit, the mistaken but well-intentioned physician can be
convicted for a simple departure from the standard of care. United States u. Vamos,
797 F.3d 1146 (2nd Cir. 1986). In Vamos, the Second Circuit reasoned that medical
practitioners have limited authority to engage in the distribution of a controlled
substance and practitioners can be stripped of that protection when they act in a
manner not generally accepted in the medical community. Id. The Second Circuit
acknowledged that this position subjects physicians to prosecution for malpractice
26
but dismissed this argument on the basis that a jury must still find proof beyond a
reasonable doubt that the physician acted outside the scope of medical practice.
In the Sixth Circuit, mere violations of professional standards are not enough
to convict. In United States v. Volkman, a physician charged with drug trafficking
under §841(a)(l) received a jury instruction: “carelessness or negligence or
foolishness on Dr. Volkman’s part are not the same as knowledge and are not enough
to find him guilty on any of these counts.” United States u. Volkman, 736 F.3d 1013,
1020 (6th Cir. 2013). The same physician prosecuted in the Fourth, Fifth and Eleventh
circuits would not receive such an instruction and can be prosecuted for professional
negligence.
The Seventh Circuit aligns with the Sixth Circuit in that the Government must
prove “something more than conduct below the usual standard of care to show an
absence of a valid medical purpose.” United States v. Chube, 538 F.3d 693, 698 (7th
Cir. 2008). In Chube, defendant sought to exclude all expert testimony that suggested
a violation of the standard of care applicable to civil medical malpractice cases. Id. at
697. He argued that such testimony admitted during trial confused the jury and
reduced the Government’s burden from criminal intent to mere negligence. Id. The
Seventh Circuit found it sufficient that the difference between civil and criminal
standards was adequately spelled out in instructions, opening, cross-examination,
and closing.
The Ninth Circuit in Feingold also tracks this Court’s language in Moore by
holding that a physician should not be subject to prosecution for mere deviations of
27
the standard of care, even if done intentionally, because it would permit the Attorney
General to prosecute any physician who steps outside the bounds of conventional
medical protocols in order to provide some sort of special treatment for uniquely
needy patients. Feingold. In explicitly disavowing the disjunctive view favored by the
Fourth Circuit in the instant case, the Ninth Circuit stated:
An instruction is improper if it allows a jury to convict a licensed
practitioner under §841(a)(l) solely on a finding that he has committed
malpractice, intentional or otherwise. Rather, the district court must
ensure that the benchmark for criminal liability is the higher showing
that the practitioner intentionally has distributed controlled substances
for no legitimate medical purpose and outside the usual course of
professional practice.
Id. at 1010.
The Eighth Circuit takes a refreshing approach to both the applicability of the
“standard of care” and the debate over the disjunctive or conjunctive interpretation
of §841(a). In United States v. Smith, the defendant challenged the use of the
malpractice standard in the trial court but was ultimately convicted. United States v.
Smith, 573 F.3d 639, 649 (8th Cir. 2009). In answering the defendant’s concerns
pertaining to the introduction of evidence related to the standard of care, the court
emphasized that the jury instructions required finding that defendant failed to
adhere to prevailing medical standards and a lack of a legitimate medical purpose for
the medication before it could convict. Id.
The DEA in its own administrative tribunal has another interpretation of 21
U.S.C. §841(a)(l) and 21 C.F.R. §1306.04. The DEA administrator decided In Re
Wesley Pope, determining that the phrases “legitimate medical purpose” and “usual
28
course of professional practice” are the same and thus interchangeable. In Re Wesley
Pope, M.D., 82 Fed. Reg. 14944, 14967 n.38 14976 (Drug Enft Admin. Mar. 23, 2017).
In Pope, the Government issued notice to Pope that his DEA registration should be
revoked exclusively on the theory that he issued prescriptions “outside the usual
course of professional practice,” which the DEA found sufficient notice because there
is no difference between the two phrases. Id. Chief DEA Administrative Law Judge
John J. Mulrooney, in a recent law review article, expressed disagreement with the
DEA Administrator’s interpretation of “legitimate medical purpose” and “usual
course of professional practice” as identical. John J. Mulrooney II & Katherine E.
Legel, Current Navigation Points in Drug Diversion Law: Hidden Rocks in Shallow,
Murky, Drug-Infested Waters, 101 Marq. L. Rev. 333, 425-426 (2017). Judge
Mulrooney cited language in United States v. Nelson, the case the administrator
relied on in Pope:
Similarly it is difficult to imagine circumstances in which a
practitioner could have prescribed controlled substances with a
legitimate medical purpose and yet be outside the usual course of
medical practice. When asked at oral argument if the two phrases were
not merely two ways of saying the same thing, appellant’s counsel was
unable to explain satisfactorily how or whether it might make a
difference if the jury had been instructed in the conjunctive as he had
requested. Nevertheless, recognizing the limits of our imagination, we
are hesitant to say that it never could make a difference, and we proceed
to consider Nelson’s argument.
United States v. Nelson, 383 F.3d, 1227, 1231 (10th Cir. 2004).
Despite differing interpretations among circuits, Courts have stood firm on
vagueness challenges to the definitions in 21 U.S.C. §841(a)(l) and 21 C.F.R.
§1306.04: United States v. Collier, 478 F.2d 268, 270 (5th Cir. 1973) (rejecting
29
“contention ... that §841(a)(l), as applied to physicians, is unconstitutionally vague”);
United States v. Darji, 609 F. App’x 320, 334 (6th Cir. 2015) (“this Court has rejected
the claim that §841 and §1306.04(a) are void for vagueness”); United States v. OrtaRosario, 469 F. App’x 140, 143 (4th Cir. 2012), cert, denied, 568 U.S. 902; 133 S. Ct.
311; 184 L. Ed. 2d 185 (2012) (rejecting medical doctor’s argument that the CSA is
impermissibly vague as applied to him because “there is no statutory definition of
‘legitimate medical purpose’ or ‘usual professional practice’”); United States v.
Brickhouse, No. 3:14-CR-124, 2016 U.S. Dist. LEXIS 59821, 2016 WL 2654359, at *4
(E.D. Tenn. Mar. 30, 2016) (“[t]he Court disagrees that §841(a)(l) and the regulation
at §1306.04 leave medical practitioners rudderless and adrift in the murky waters of
criminal liability”); United States v. Quinones, 536 F. Supp. 2d 267, 274 (E.D.N.Y.
2008) (rejecting vagueness argument because the phrase “within the usual scope of
professional practice” has an “objective meaning that prevents arbitrary prosecution
and conviction: neither the government nor the jury is free to impose its own
subjective views about what is and is not appropriate; rather, the government is
obliged to prove, and the jury constrained to determine, what the medical profession
would generally do in the circumstances”); United States v. Birbragher, 576 F. Supp.
2d 1000, 1013 (N.D. Iowa 2008), affd, 603 F.3d 478 (8th Cir. 2010) (“courts have held
the language ‘legitimate medical purpose’ and ‘usual course of his professional
practice’ is not unconstitutionally vague as applied to physicians”); United States v.
Prejean, 429 F. Supp. 2d 782, 805 (E.D. La. 2006) (rejecting argument that this
framework is vague because “the medical community has not established clear,
30
nationwide standards for what is considered ‘legitimate medical purpose’ in the field
of pain management”).
This Court is presented with a trend of jurisprudence drifting far from its 40year precedent, a vast circuit split, and the agency charged with enforcing the CSA
being at odds with its Chief Administrative Law Judge in interpreting the applicable
standard for physician conduct. It is time for this Court to weigh in and re-affirm its
holding in Moore so that the medical community can have a clear definition of the
conduct required to conform to 21 U.S.C. §841(a)(l) and 21 C.F.R. §1306.04.
e. There is no generally accepted standard for prescribing
controlled substances in the U.S.
The crucial issue for physicians in the Second, Fourth, Fifth, and Eleventh
circuits who are subjected to an objective standard of care analysis for criminal
liability is that the pain management and addiction medicine fields are rapidly
evolving and standards are constantly shifting. In 1986, opioid maintenance therapy
using high doses of powerful narcotics was considered to be a “safe, salutary, and
more humane alternative to the options of surgery or not treatment in those patients
with intractable non-malignant pain and no history of drug abuse.” R.K. Portenoy &
K.M. Foley, Chronic Use of Opioid Analgesics in Non-Malignant Pain: Report of 38
Cases, 25(2) PAIN, 171-86 (May 1986). In the 1990s, chronic pain management was
a significant healthcare policy concern, and practitioners were advised by the Joint
Commission, an accrediting body, to treat pain as a fifth vital sign. Andrew
Rosenblum et al., Opioids and the Treatment of Chronic Pain: Controversies, Current
31
Status, and Future Directions, 16(5) EXP. CLIN. PSYCHOPHARMACOL, 405 (2018).
Since the “pain as the fifth vital sign” movement, physician opioid prescribing surged,
becoming one of the current opioid epidemic’s causes. Id. This was principally because
Centers for Medicare and Medicaid Services (CMS) tied post-hospitalization patient
survey questions about the effectiveness of a patient’s pain management to physician
reimbursement and performance rankings. Only recently has the tide turned. A
proposed rule to remove the policy was only introduced in 2016. 81 Fed. Reg. 45603.
This reversal was done contemporaneously with a sweeping drug policy change and
the implementation of the Centers for Disease Control (CDC) Guidelines for
Prescribing Opioids for Chronic Pain. Centers for Disease Control and Prevention,
CDC Guidelines for Prescribing Opioids for Chronic Pain, (last updated Aug. 29, 2017), https://www.cdc.gov/drugoverdose/prescribing/guideline.html.
When the Government “woke up” in 2016, it steered too hard in the other
direction by implementing a substantial number of policy changes, including the CDC
guidelines: while only intended as a “guideline,” they read as a standard of care, and
State Medical Boards began adopting them into their administrative code. Doug
Campos-Outcalt,
M.D., M.P.A.,
Opioids for Chronic Pain: The CDC’s
12
Recommendations, 65(12) J. FAM. PRACT. 906-909 (Dec. 2016) (“given the
prominence of the CDC, this clinical guideline will likely be considered standard of
care for family physicians”). In 2019, Medicare adopted a rule, coming directly from
the CDC guidelines, to deny coverage, in certain circumstances, for opioid
prescriptions issued for more than seven days and over a 50 morphine milligram
32
equivalent dose. CMS, Advance Notice of Methodological Changes for Calendar Year
(CV) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment
Policies and 2019 Draft Call Letter, (Feb. 1, 2018). Within one year of the guidelines’
creation, nine states added statutes and administrative rules adopted from those
guidelines. Andy Baker-White, A Look at State Legislation Limiting Opioid
Prescriptions, ASTHO (Feb. 23, 2017), http://www.astho.org/StatePublicHealth/ALook-at-State-Legislation-Limiting-Opioid-Prescriptions/2-23-17/.
The CDC guidelines have been introduced as evidence in many opioid
prosecutions over the last four years. See United States v. Lague, 971 F.3d 1032, 1041
(9th Cir. 2020) (provider convicted of prescribing pain medication multiple times over
the “CDC limit for exercised induced shoulder pain”); United States v. Newman, No.
3:19-CR-59-TAV-DCP, 2020 U.S. Dist. LEXIS 221891, at *37 (E.D. Tenn. Sep. 8,
2020) (CDC guidelines related to opioid thresholds included in search warrant
affidavit to secure a search).
Just as the Circuits shifted to anchor violations of 21 U.S.C. §841(a)(l) and 21
C.F.R. §1306.04 to a violation of the objective “standard of care,” that “standard of
care” became heightened, more complex, and difficult to follow. Four years after the
sweeping policy change brought about by the CDC guidelines, in 2020 the American
Medical Association publicly criticized the guidelines and called for widespread
changes. It released a paper urging the CDC to make significant revisions to its 2016
Guidelines for Prescribing Opioids for Chronic Pain, which have been touted as a
medical standard by federal prosecutors, to protect patients with pain from the
33
ongoing unintended consequences and misapplication of the guidance. American
Medical Association, AMA Urges CDC to Revise Opioid Prescribing Guidelines, June
18,
2020,
https://www.ama-assn.org/press-center/press-releases/ama-urges-cdc-
revise-opioid-prescribing-guideline, accessed Jan. 19, 2021.
Since 1985, physicians have been subject to shifting and evolving standards.
Questions of professional disagreement cannot be the basis for prosecution because
the risks of medical progress and proper pain management become too great, which
will lead to a suffering patient population. This is precisely why this Court in
Gonzales refused to engage in medical questions and determined this is better left to
the state and its police powers.
Justice Stewart’s foretelling in Moore, that we are embarking on dubious
grounds when we begin prosecuting physicians for professional disagreements, has
rung true. Misinterpretation of the phrases “legitimate medical purpose,” “course of
professional practice,” and “bounds of professional practice” have led criminal courts
to embark on an exploration of civil malpractice issues when determining whether a
physician should spend years, if not decades, in jail. Lack of consensus about the
criminal standard to be applied has somehow survived vagueness challenges
notwithstanding the fact that courts cannot agree over whether the standard is
objective or subjective, disjunctive or conjunctive, and even whether “legitimate
medical purpose” and “usual course of professional practice” mean the same thing.
Meanwhile, the practice of medicine hangs in the balance: pain management,
addiction medicine, and family practice physicians alike remain fearful of
34
prescribing, until some definitive standard is set forth so that this “risk adverse”
population can know the limits of their liability.
CONCLUSION
For the forgoing reasons, the petition for a write of certiorari should be
granted.
Respectfully Submitted,
CHAPMAN LAW GROUP
Dated:
-a
Ronald W. Chapman II, LL.M.
1441 W. Long Lake Rd., Ste. 310
Troy, MI 48098
T: (248) 644-6326
F: (248) 644-6324
rwchapman@chapmanlawgroup .com
Counsel for Petitioner-Appellant
George P. Naum III
35
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.